Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions

NCT03332264 | Completed

• 1 other identifier: SP01
• Study Type: interventional
• Target: 224
• Locations: 2 countries
• Sites: 10

Brief Summary

Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.

Conditions

Stenosis; Occlusion; Restenosis

Keywords

PAOD; drug coated balloon; drug coated stent; percutaneous transluminal angioplasty (PTA)

Outcome Measures

Primary Outcomes (1)

• Percent diameter stenosis at 1 year post intervention in successfully treated patients

  by quantitative angiography

  12 +/- 2 months

Secondary Outcomes (3)

• Late Lumen Loss

  12 months

• Binary restenosis

  6,12, 24, 36 months

• Target lesion revascularization

  6, 12, 24, 36 months

Other Outcomes (2)

• Event-free survival

  6, 12, 24, 36 months

• Walking distance

  6, 12, 24, 36 months

Study Arms (3)

Drug coated balloon catheter

EXPERIMENTAL

PTA with paclitaxel coated "SeQuent Please OTW"

Device: SeQuent Please OTW

Drug coated stent

ACTIVE COMPARATOR

PTA with paclitaxel coated "Eluvia Vascular Stent System"

Device: Eluvia Vascular Stent System

Uncoated stent

ACTIVE COMPARATOR

PTA with bare nitinol stent (as commonly used in site)

Device: Nitinol stent

Interventions

SeQuent Please OTW DEVICE

Dilatation of occluded or highly stenosed vessel with paclitaxel-coated balloon catheter

Drug coated balloon catheter

Eluvia Vascular Stent System DEVICE

Dilatation of occluded or highly stenosed vessel with paclitaxel-coated stent

Drug coated stent

Nitinol stent DEVICE

Dilatation of occluded or highly stenosed vessel with uncoated bare nitinol stent

Uncoated stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PAOD and Rutherford classes 2 - 4 (pain-free walking distance \<500 m)
• eligible for peripheral revascularization by means of PTA
• peripheral lesions in the superficial femoral artery (SFA) and / or the PI-segment of the popliteal artery (A.pop.)
• minimum diameter stenosis of ≥70%
• treatment length at least 15 cm (lesion length at least 13 cm)
• maximum of lesions to be treated should be 2 (all treated lesions should be treated within the randomization to the study group, i.e. either coated balloon catheters or coated stents or bare nitinol stents); in case of two lesions matching the eligibility criteria, the one presenting the worst attributes (length and stenosis degree) should be chosen as target lesion
• long diffuse stenosis with or without occlusions may only be divided in separate lesions if non-stenotic (i.e. \<50% stenosis) segments in between the lesions extent to \>2 cm, otherwise vessel segments will be treated as a single extended lesion
• eligible for an operative vascular intervention in case of complications during the PTA

You may not qualify if:

• Rutherford class 1,5 or 6
• more than two stenotic lesions in the target vessel requiring treatment
• inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to the study lesion
• in-stent restenosis of the study lesion
• strongly calcified lesions with circumferential presence of calcifications and a lesion calcification length of \>4 cm
• reference vessel diameter \<4 mm and \>6 mm
• guide wire could not be successfully advanced across the lesion
• lesions below the knee requiring treatment
• target lesion is located in the PII-segment of the popliteal artery (A.pop.) or within a bypass graft
• acute thrombosis of the study lesion requiring lysis or thrombectomy prior to the treatment of the study lesion
• potential loss of leg due to critical or acute ischemia
• no patent distal run-off vessel
• medical reason against double anti-platelet therapy in anti-coagulated patient, e.g., receiving coumarine or conditions which prevent the intake of the double anti-platelet therapy for two months
• female patient who is pregnant or lactating
• under 18 years of age

Sponsors & Collaborators

• InnoRa GmbH: lead
• Boston Scientific Corporation: collaborator
• B. Braun Melsungen AG: collaborator

Study Sites (10)

Medizinische Universität Graz

Graz, Austria

Location

RoMed Klinikum

Rosenheim, Bavaria, Germany

Location

Klinikum Arnsberg, Karolinen-Hospital

Arnsberg, Germany

Location

Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Location

Ihre-Radiologen Standort Franziskus-Krankenhaus

Berlin, Germany

Location

Ihre-Radiologen Standort Jüdisches Krankenhaus

Berlin, Germany

Location

Vivantes Klinikum Neukölln

Berlin, Germany

Location

Diakonissenkrankenhaus Flensburg

Flensburg, Germany

Location

SANA Kliniken Lübeck

Lübeck, Germany

Location

Universitätklinikum Lübeck

Lübeck, Germany

Location

MeSH Terms

Conditions

Constriction, Pathologic; Bites and Stings

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Gunnar Tepe, MD

  RoMed Klinikum Rosenheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Corelab will be masked for the bare metal and paclitaxel coated stent arm.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Vessel patency will be compared by quantitative angiography at 12 months in patients who have been treated either with paclitaxel coated balloon catheter, paclitaxel coated stent or bare metal stent in femoropopliteal arteries

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 6, 2017
• Study Start: March 30, 2017
• Primary Completion: January 31, 2022
• Study Completion: December 12, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

AU (1); DE (9)